COGESIC Tablet Ref.[50555] Active ingredients: Codeine Paracetamol

Paracetamol

COGESIC contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

• Do not use continuously for more than 5 days without consulting your doctor.
• Dosages in excess of those recommended may cause severe liver damage.
• Consult your doctor if no relief is obtained with the recommended dosage.
• Patients suffering from liver or kidney disease should take paracetamol under medical supervision.

Codeine

COGESIC contains codeine and exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

• Codeine should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment
• Codeine should be given with caution to patients with:
  • hypothyroidism,
  • adrenocortical insufficiency,
  • myasthenia gravis,
  • impaired renal function,
  • impaired liver function,
  • prostate hypertrophy
  • shock or
  • inflammatory or obstructive bowel disorders.

The dosage should be reduced in elderly and debilitated patients. The administration of codeine during labour may cause respiratory depression in the newborn infant (see “HUMAN REPRODUCTION”).

COGESIC contains sucrose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorplion or sucrase- isomaltase insufficiency should not take COGESIC.

• Codeine should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment (see WARNINGS AND SPECIAL PRECAUTIONS).
• The depressant effects of codeine are enhanced by depressants of the central nervous system such as:
  • alcohol,
  • anaesthetics,
  • hypnotics and sedatives,
  • phenothiazines and tricyclic antidepressants

The administration of codeine during labour may cause respiratory depression in the newborn infant (see WARNINGS AND SPECIAL PRECAUTIONS).

COGESIC may causes drowsiness. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

Paracetamol

Sensitivity reactions resulting in reversible rash or blood disorders may occur.

Codeine

Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis, circulatory failure, hypotension, deepening coma, muscle rigidity. Micturilion may be difficult and there may be ureteric ar biliary spasm.

Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur. Codeine may have an antidiuretic effect.